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Axim® Biotechnologies Earns GMP License From Dutch Ministry of Health to Produce Cannabinoid-Based Pharmaceutical Products
Axim® Biotechnologies Earns GMP License From Dutch Ministry of Health to Produce Cannabinoid-Based Pharmaceutical Products.
About this update from Axim Biotechnologies, Inc.
[{"type":"text","content":"\nNew License Allows Leading Cannabinoid Biopharmaceutical Company to Advance Production of Clinical Trial Products\n NEW YORK, Oct. 16, 2018 (GLOBE NEWSWIRE) -- AXIM® Biotechnologies, Inc. (“AXIM® Biotech” or “AXIM”) (OTCQB: AXIM), a world leader in cannabinoid research and development, today announced that it has received a manufacturing license from the Dutch Ministry of Health, Welfare and Sports for the production, according to Good Manufacturing Practices (“GMP”), of the company’s pharmaceutical products to be used in clinical trials. Effective Oct. 1, 2018, the license allows AXIM to produce its cannabinoid-based pharmaceutical drug candidates for use in human clinical trials for multiple indications. Under the new GMP license, AXIM will begin production of its flagship pharmaceutical product MedChew Rx®, which will undergo clinical trials targeting the treatment of pain and spasticity in Multiple Sclerosis (MS) patients. The company recently announced positive results from stability and dissolution tests performed on MedChew Rx®, indicating the Active Pharmaceutical Ingredients (APIs) remained stable throughout the test and had an availability greater than 90%. The company also plans to conduct a bioequivalence study on its own product containing Dronabinol, comparable to the Food and Drug Administration (FDA)-approved Marinol, for the treatment of nausea associated with cancer treatment and patients with AIDS, for which it has already received a Pre-Investigational New Drug Application (Pre-IND) approval from the FDA in the United States. Additional target indications for these programs include drug-related psychosis, Restless Legs Syndrome (RLS), Irritable Bowel Syndrome (IBS), Parkinson’s Disease (PD), and dementia, among others. “It is a significant accomplishment for AXIM to receive a GMP license from the Dutch Ministry of Health, which will help propel our clinical product pipeline forward,” said George E. Anastassov, MD, DDS, MBA and Chief Executive Officer of AXIM® Biotech. “This GMP license illustrates our commitment to high-quality production of cannabinoid-based pharmaceutical products. AXIM has been working in the Netherlands for many years and considers the country to be a leader in cannabinoid research.” Wh...